Status: Partially superseded | |||
AWMSG ADVICE PARTIALLY SUPERSEDED BY NICE GUIDANCE ISSUED FEBRUARY 2015, JANUARY 2016, FEBRUARY 2016 and JUNE 2021. Refer to TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy, TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed, TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis and TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed for full guidance on NICE recommendations, including any specific restrictions on the use of the technology. Infliximab (Remsima®) is recommended as an option for restricted use within NHS Wales. Infliximab (Remsima® should be prescribed within its licensed indications in accordance with NICE or AWMSG guidance for infliximab (Remicade®), the reference product. Infliximab (Remsima®) should be prescribed by brand name to avoid automatic substitution and therefore help with pharmacovigilance. |
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Medicine details |
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Medicine name | infliximab (Remsima®) | ||
Formulation | 100 mg powder for concentrate for solution for infusion | ||
Reference number | 2254 | ||
Indication | In combination with methotrexate, for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active rheumatoid arthritis when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate; and adult patients with severe, active and progressive rheumatoid arthritis not previously treated with methotrexate or other DMARDs. Treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant, or who are intolerant to or have medical contraindications for such therapies. Treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Treatment of severe, active Crohn’s disease in children and adolescents aged six to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy, or who are intolerant to or have contraindications for such therapies. Treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Treatment of severely active ulcerative colitis in children and adolescents aged six to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy. Treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate, in combination with methotrexate, or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. Treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultraviolet A (PUVA) |
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Company | Celltrion Healthcare Co Ltd | ||
BNF chapter | Musculoskeletal & joint diseases | ||
Submission type | Full | ||
Status | Partially superseded | ||
Advice number | 4314 | ||
NMG meeting date | 19/11/2014 | ||
AWMSG meeting date | 17/12/2014 | ||
Ratification by Welsh Government | 10/03/2015 | ||
Date of issue | 11/03/2015 | ||
Date of last review | 27/03/2018 | ||
NICE guidance |
TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis |